CN103479403B - System and method for guiding focused ultrasonic energy release by surgical navigation system - Google Patents

Abstract

A system and method for releasing energy by guiding focused ultrasonic wave with operation navigation system is used to guide a focused energy to a target point. The system comprises a focusing ultrasonic device, a surgical navigation system and a fixing clamp, wherein the surgical navigation system completes a correction procedure according to an image of a part to be processed of an individual, a focusing point of the focusing ultrasonic device and a tracking point provided by the surgical navigation system, and establishes a position relation between the focusing point and the image of the part to be processed, so that the surgical navigation system can identify the focusing point and guide focusing energy to a target point.

Description

System and method for guiding focused ultrasonic energy release by surgical navigation system

technical field

The invention relates to a focused ultrasonic system, in particular to a system and an operation method for guiding focused ultrasonic energy to be released by a surgical navigation system.

Background technique

Focused ultrasound has very good penetration in human tissue, so it can transmit energy to deep parts, and concentrate most of the energy of ultrasound to the focal point. The focal point of the generated ultrasound is about the size of a grain of rice. The existing clinical applications include: thermal ablation of tumors, opening of the blood-brain barrier, stimulation and regulation of nerve cells, etc. Because focused ultrasound concentrates most of the energy at the focal point, it can destroy deep tissues under completely non-invasive conditions, and the energy absorbed by intermediate tissues is extremely low without causing damage. Therefore, in addition to being used as auxiliary surgical thermal ablation, especially in tumor treatment, focused ultrasound can also be applied to other clinical medical biology, such as stimulating local or deep cells, increasing vascular permeability, and dissolving thrombus. , and local drug release, etc.

However, one of the main problems encountered in the current application of focused ultrasound is that the focused ultrasound lacks a good positioning guide, so that the ultrasonic energy cannot be directed to the desired treatment in a simple and precise manner. on the target point.

The current guiding method of focused ultrasound is guided by Magnetic Resonance Imaging (MRI). This guidance method mainly uses ultrasonic waves to cause water molecules to vibrate to generate heat at the focal point, so as to track the signal on the MRI image and guide the focal point to the area to be treated. This method is certainly an instant observation in heat therapy, but it is worth noting that this technology must fully integrate all focused ultrasound devices and embed them in the MRI system, not only requires advanced MRI manufacturing capabilities to achieve Line reorganization also has disadvantages such as difficult system design and high cost. Moreover, for the application of guided focused ultrasound to open the blood-brain barrier of the brain, there is currently no guiding system that can be used clinically.

In addition, the use of focused ultrasound to open the blood-brain barrier is different from thermal therapy, and MRI cannot be used to achieve instant observation. In other words, the operator needs to inject the MRI contrast agent again after the focused ultrasonic treatment, and conduct the MRI scan again to confirm whether the blood-brain barrier is open or not, which also causes cumbersome operation. In addition, the current MRI-guided focused ultrasound cannot perform real-time feedback control.

On the other hand, for many courses of treatment that require multiple doses, such as chemotherapy for cancer patients, if MRI scanning is required for each focused ultrasound treatment that is combined with drug administration, it will consume a considerable amount of time. time and medical resources.

Therefore, how to propose an innovative positioning guidance method to effectively assist the focused ultrasound to focus its energy on the patient's target point is one of the problems that need to be solved urgently for those skilled in this technical field.

Contents of the invention

The main purpose of the present invention is to provide a system and method for guiding focused ultrasonic energy with a surgical navigation system and its method, which is to use the surgical navigation system to guide focused ultrasonic energy and become a novel and practical method. system and its method of operation.

Another object of the present invention is to provide a system and method for guiding focused ultrasound to release energy by using a surgical navigation system, which is combined with a surgical navigation system to perform precise energy release, which can not only accurately guide ultrasound The energy is directed to the target point, so that the ultrasonic energy can accurately cover the target point in the tissue, and it can also be used to open the blood-brain barrier in the brain.

Another object of the present invention is to provide a system and method for guiding focused ultrasound to release energy with a surgical navigation system, which does not need to integrate the focused ultrasound device into the MRI system, and does not need to be in the MRI room during operation. In this way, the flexibility of system usage is increased, and the expensive cost of the prior art is effectively reduced.

In order to achieve the above-mentioned purpose, the present invention proposes a system that uses a surgical navigation system to guide focused ultrasonic waves to release energy, which is used to guide a focused energy to a target point. This energy release system includes: a focusing type ultrasonic device, a surgical navigation system, and a fixed fixture. Wherein, the focused ultrasonic device can generate a focused point, so as to release the focused energy at the target point. The surgical navigation system is electrically connected to the focused ultrasonic device, which includes a calibration unit, which is used to establish the positional relationship between the focal point and an image of an individual body to be treated, perform a calibration coordinate calibration procedure, and enable the surgical navigation The system identifies the focal point. The fixing fixture is used to fix the part of the individual to be treated.

In addition, the focused energy described above can be applied to thermal cauterization, local or deep stimulation of cells, local or deep regulation of cells, increase of vascular permeability, local dissolution of thrombus, local drug release or opening of the blood-brain barrier in the brain.

Applicable target points of the system of the present invention can be located at the place where the surgical navigation system can be operatively guided, such as tissues of the central nervous system, brain, spinal cord or tissues covered by hard tissues.

On the other hand, the present invention discloses a method for guiding focused ultrasonic energy to release energy by using a surgical navigation system, which is used to guide a focused energy on a target point, including the following steps:

(1) Provide a system that uses a surgical navigation system to guide focused ultrasound to release energy, which includes a surgical navigation system, a focused ultrasound device, and a fixing fixture;

(2) Obtain an image of a body to be processed;

(3) providing a focal point of the focused energy in a spatial location;

(4) Establishing the positional relationship between the focal point and the image of the part to be processed of the individual;

(5) Correcting the coordinates of the spatial position and the image of the part to be treated of the individual, so that the surgical navigation system can identify the focal point;

(6) using the surgical navigation system to guide the focal point to the target point; and

(7) Make the focused ultrasonic device release the focused energy at the target point.

In the following, a detailed description will be given through specific embodiments in conjunction with the attached drawings, and it will be easier to understand the purpose, technical content, characteristics and effects of the present invention.

Description of drawings

Fig. 1 is a flow chart of an ultrasonic treatment procedure guided by a surgical navigation system guiding a focused ultrasonic energy release energy system according to the present invention.

FIG. 2 is a flow chart of steps of a method for energy release by guiding focused ultrasound with a surgical navigation system according to an embodiment of the present invention.

FIG. 3 is a block diagram of a system for guiding focused ultrasound to release energy by a surgical navigation system according to an embodiment of the present invention.

4A to 4D are schematic diagrams of a head position fixing device and a fixing procedure before focused ultrasonic treatment according to an embodiment of the present invention.

5A and 5B are schematic diagrams of an ultrasonic device, tracking points P1 and P2 , a dummy, and various reference points when a calibration procedure is performed according to an embodiment of the present invention.

FIG. 5C and FIG. 5D are schematic diagrams of tying the water bag and mounting the track after the calibration procedure is completed according to an embodiment of the present invention.

FIG. 6 is a flow chart of steps for performing a calibration procedure according to an embodiment of the present invention.

Fig. 7 is a diagram showing the results of an MRI experiment using a surgical navigation system to guide focused ultrasound to release energy to open the blood-brain barrier in the brain of an animal according to an embodiment of the present invention.

FIG. 8A and FIG. 8B are diagrams of R1 analysis and brain region analysis after ultrasonic focusing according to FIG. 7 .

9A and 9B are data diagrams of experimental results of using a surgical navigation system to guide multi-point focused ultrasound to release energy to open the blood-brain barrier in the brain of an animal according to an embodiment of the present invention.

Fig. 10 is a diagram of difference data between the focused target point and the actual location where the effect is produced by using the present invention.

11A to 11D are schematic structural views of an aligner using multi-point focused ultrasonic waves according to another embodiment of the present invention.

FIG. 12A to FIG. 12D are schematic diagrams of focusing regions using multi-point focused ultrasonic waves according to an embodiment of the present invention.

13A and 13B are schematic diagrams of subharmonic composition in the ultrasonic echo spectrum when the blood-brain barrier in the brain is opened according to an embodiment of the present invention.

13C and 13D are schematic diagrams of superharmonic components in the ultrasonic echo spectrum when the blood-brain barrier in the brain is opened according to an embodiment of the present invention.

FIG. 14 is a flow chart of real-time control steps for multi-point focusing according to an embodiment of the present invention.

Explanation of reference signs: 10-focused ultrasonic device; 20-surgical navigation system; 24-correction tracker; 26-dummy; 30-fixing fixture; 40-patient; 50-water bag; 102-signal generator; 104-signal amplifier; 106-ultrasonic probe; 107-focus area; 108-power measuring device; 302-sliding track; 304-fixed track; 306-fixing mechanism.

detailed description

The present invention mainly proposes a method of using a surgical navigation system to guide the release of focused ultrasonic energy, which is to guide the non-physical focused ultrasonic energy from the surgical navigation system originally used to guide physical surgical instruments, becoming a new type of And practical operating system.

According to the system and its operation method proposed by the present invention, it is not necessary to integrate the focused ultrasonic equipment into the MRI system, and the original surgical navigation system of each hospital can be used to match the focused ultrasonic device, which not only increases the flexibility of the operating system, but also Focused ultrasonic treatment does not need to be operated in the MRI scanning room, and also improves the existing treatment process of ultrasonic energy release.

The following detailed description of the present invention is based on "Using the surgical navigation system to guide focused ultrasound to release energy to focus the energy on a target point in the patient's brain, thereby opening the blood-brain barrier of the brain" The preferred examples are described, but not intended to limit the scope of the invention. Any application of the technical idea of the present invention to other parts of the body that can be operated and guided by the surgical navigation system, such as the tissues of the central nervous system, the brain, the spinal cord, or tissues covered by hard tissues is also within the scope of the present invention.

First, please refer to FIG. 1 , which is an example of focused ultrasonic treatment on the brain to illustrate the difference between the prior art and the present invention. The existing general procedures for focused ultrasound treatment using MRI guidance include Step S11 to Step S41, Step S61 and Step S71. First, in step S11, the patient is diagnosed and diagnosed with a brain lesion. In step S21, the physician selects a patient who is suitable for focused ultrasound treatment. In step S31, the course of treatment is planned for the patient, and in step S41, MRI contrast is used to locate the patient's brain where focused ultrasonic treatment is to be performed, and focused ultrasonic treatment is performed. In step S61, MRI contrast is performed again to confirm the effect of the focused ultrasonic treatment. In step S71, the physician conducts curative effect tracking. If multiple focused ultrasound treatments are required, such as chemotherapy for brain cancer patients, the patient needs to go through the above procedure again after each administration.

The general procedure of the present invention includes steps S11 to S51 and step S71. Different from the prior art, the present invention captures the brain image of the patient in step S41 to determine the area to be treated with focused ultrasound. This step can Using MRI contrast, computer tomography (Computed Tomography, CT) or other methods to obtain brain images of patients. In step S51, the surgical navigation system guides the focused ultrasound to the target point to be treated according to the brain image of the patient. feedback control. If multiple focused ultrasound treatments are required, the surgical navigation system only needs to conduct guidance based on the previously obtained brain images for each treatment, without repeated MRI angiography. After the focused ultrasound treatment procedure is over, the doctor can use MRI contrast to confirm the effect of the focused ultrasound treatment again. Finally, in step S71, the physician conducts curative effect tracking.

From the above, it can be seen that the present invention is fundamentally different from the existing process. The system design of the prior art needs to integrate the focused ultrasound into the MRI equipment, and the steps S41 to S61 of the prior art need to be completed in the MRI scanning room. When multiple focused ultrasound treatments are required, MRI contrast is required each time, which is not only cumbersome to operate, but also consumes a considerable amount of medical resources. However, the system of the present invention does not need to be integrated in MRI equipment, and therefore, does not require complicated designs. Moreover, the system of the present invention does not need to be performed in an MRI scanning room at step S51. When multiple focused ultrasound treatments are required, the surgical navigation system can be used to repeatedly perform positioning and guidance based on previously obtained images. It is evident that there are considerable differences between the present invention and existing procedures.

In addition, it is worth noting that the source of images of the patient’s parts to be treated required by the surgical navigation system disclosed in the present invention is not limited to the use of MRI angiography, and computer tomography (Computed Tomography, CT) or other image sources can also be used. The present invention uses MRI imaging as an example to explain the technical idea of the present invention, but it is not intended to limit the scope of the present invention.

Please refer to FIG. 2 , which is a flow chart of steps of a method for guiding focused ultrasound to release energy by using a surgical navigation system according to an embodiment of the present invention. This method is suitable for guiding focused ultrasound to release its energy to patient tissues On a target point, it mainly includes steps S202, S204, S206 and S208.

FIG. 3 is a block diagram of a system for guiding focused ultrasound to release energy by a surgical navigation system according to an embodiment of the present invention. 4A to 4D are schematic diagrams of energy release through the track on the ultrasound probe frame corrected by the surgical navigation system according to an embodiment of the present invention.

The following is an embodiment of the present invention applied to brain focused ultrasonic treatment. Before performing focused ultrasonic treatment, it is necessary to provide a fixing mechanism to fix the patient's head, thereby fixing the head position during focused ultrasonic treatment. Generally speaking, this fixing mechanism can fix the treatment site during treatment That's it. Please refer to FIG. 4A to FIG. 4B , the fixing mechanism 306 can be a thermoplastic molding mold, which can be formed by heating, so that the patient 40 is closely connected with the thermoplastic molding mold, and can be disassembled repeatedly. The patient 40 can wear the fixing mechanism 306 and go in and out of the image scanning room for image scanning.

After that, as shown in FIG. 4C , the fixed track (fixed track) 304 is fastened with the fixing mechanism 306 . If the patient 40 needs to undergo focused ultrasonic treatment multiple times, the fixed mechanism 306 dedicated to the patient 40 can be put on to fix the treated part, without repeated image scanning, and the information of the first image scan can be directly used.

FIG. 5A to FIG. 5D are schematic diagrams of some devices when a calibration procedure is performed according to an embodiment of the present invention. Please refer to FIGS. 2-4 and FIGS. 5A-5D together for the description of the operating system and its method disclosed in the present invention, and the details are as follows.

Firstly, in step S202, the present invention provides a fixing fixture 30, and part of the fixing fixture 30 may be a device similar to a stereotactic frame, which is used to fix the head of the patient 40 (as shown in Figure 4A- 4C), wherein the fixing fixture 30 includes a sliding track (sliding track) 302 , a fixed track (fixed track) 304 , and a fixing mechanism 306 .

In step S204 , the previously captured brain image of the patient 40 is obtained (refer to step 41 in FIG. 1 ). Then, in step S206 , a surgical navigation system (neuro-navigation system) 20 is provided to guide a focused ultrasound device (focused ultrasound system) 10 to the target point.

Wherein, the surgical navigation system 20 includes a calibration unit, which is used to provide at least two tracking points P1 and P2. The tracking point P1 provides a fixed reference coordinate. It is generally set at a place where the relative position of the part to be treated will not change, preferably on the fixed track 304 of the above-mentioned fixed fixture 30 . The ultrasound probe 106 of the focused ultrasound device is set on the sliding track 302 of the above-mentioned fixture 30 , and another tracking point P2 of the surgical navigation system 20 is set on the ultrasound probe 106 of the focused ultrasound device 10 . The present invention completes a calibration procedure based on the tracking points P1, P2, the brain image of the patient 40 obtained in step S204, and the focus point O of the focused ultrasound device 10, thereby determining the position of the target point to be processed.

Finally, in step S208, the focused ultrasound device 10 can release its energy on the determined target point, so as to achieve the purpose of increasing the permeability of the local tissue at the target point in the brain.

According to an embodiment of the present invention, as shown in FIG. 3 , the focused ultrasonic device 10 is electrically connected to the surgical navigation system 20 and includes a signal generator (signal generator) 102, a signal amplifier (signal amplifier) 104, and an ultrasonic probe. (focusedultrasoundtransducer) 106, and a power measuring device (powermeter) 108. Wherein, the signal generator 102 outputs an ultrasonic signal V1; the signal amplifier 104 is connected to the signal generator 102 to amplify the ultrasonic signal V1 into focused energy V2. The ultrasonic probe 106 is connected to the signal amplifier 104 to release the focused energy V2 to the target point. The power measuring device 108 is connected to the ultrasonic probe 106 to measure the energy of the focused energy V2.

In an embodiment, the ultrasonic signal V1 may be a sinusoidal signal, for example. The center frequency of the focused energy V2 can generate resonance with the ultrasound probe 106 .

In this embodiment, the surgical navigation system 20 may include a computer unit (computer unit) and related software, hardware, memory, etc., which record the brain image of the patient 40 and provide the above-mentioned two tracking points P1, P2 , so that the surgical navigation system 20 completes the calibration procedure according to the brain image of the patient 40 , the focus point O and the tracking points P1 and P2 of the focused ultrasound device 10 . In this embodiment, the tracking point P1 is set on the fixed track 304 of the fixing fixture 30, making it a reference point with fixed coordinates in space, and the tracking point P2 is an induction point set on the ultrasonic probe 106. point.

Since the fixing fixture 30 includes a sliding track (sliding track) 302 and a fixed track (fixed track) 304, it is thus designed that the tracking point P1 provided by the surgical navigation system 20 is set on the fixed track 304 to match another tracking point P2 carries out the calibration process of determining the target point, while the ultrasonic probe 106 is set on the sliding track 302 , and the focused energy V2 is released on the determined target point through the reciprocating sliding of the slidable sliding track 302 . Among them, it is worth noting that, as shown by the dotted line in Fig. 4D, since the sliding track 302 has 360 degrees of freedom and can pivot to three axes in space, thus, the ultrasonic probe arranged on it 106 can naturally also move/rotate arbitrarily in space, and release its focused energy when reaching a determined target point.

In addition, when the present invention selects the fixing mechanism 306, it must be noted that its material must be suitable for the image scanning process. For example, if the image of the part to be treated is captured by MRI scanning, it is necessary to avoid using inappropriate materials to avoid being affected. The interference of unexpected signals leads to misjudgment of results.

Next, the present invention will describe in detail how to integrate the surgical navigation system 20 with the focused ultrasound device 10 and how the surgical navigation system 20 completes its calibration procedure.

First of all, for two completely different instruments (the focused ultrasound device 10 and the surgical navigation system 20 ), how to combine them stably requires a new alignment procedure.

In the calibration of traditional solid surgical instruments, a calibration tracker (calibration tracker) 24 connected to the surgical navigation system 20 is provided in the program to assist calibration (different from the above-mentioned tracking points P1 and P2). The calibration tracker 24 can introduce any physical surgical instruments that may be used during the operation to the navigation system for recognition through a calibration program (calibration). Since how to use the surgical navigation system to calibrate a physical surgical instrument is an existing technology, it will not be described in detail. The present invention will focus on how to propose a novel calibration procedure to calibrate a non-substantial ultrasonic focus O, which is described in detail as follows.

Please refer to FIG. 5A , FIG. 5B and FIG. 6 , which are schematic diagrams of a calibration procedure according to an embodiment of the present invention and an illustration of a flow chart of steps thereof.

First, as shown in step S602, the present invention first confirms the focal point O of the focused ultrasonic device. The focus point O (and its complete three-dimensional sound field distribution) can be obtained by precise ultrasonic underwater sound field measurement. After that, in order to define the energy focus point O of the focused ultrasonic device, the present invention provides a dummy 26 specially designed for the ultrasonic probe to be used together with the calibration tracker 24 . In this embodiment, the above-mentioned dummy 26 is a T-shaped dummy, which is mainly used to assist the calibration tracker 24 to precisely point out the focus of the focused ultrasound in space. After that, mount the focused ultrasonic probe 106 on the T-shaped dummy 26 (see FIG. 5B ). At this point, the virtual energy focus will be replaced by the physical tip of the T-shaped dummy.

Afterwards, in step S604, point out the position of the focal point O through the dummy 26, and carry out the correction procedure in the image: first, input the patient's brain image into the navigation system, and select several reference points R1, R2 on the patient's head , ..., Rn (refer to Figure 5B), the navigation system first memorizes these reference points R1, R2, ..., Rn respectively and confirms the coordinates corresponding to these reference points in the brain image, so that with the assistance of the calibration tracker 24, Compare the coordinates to determine whether they are all smaller than the tolerable error amount. The calibration procedure in this embodiment is to install the sensing point P2 on the focused ultrasonic probe 106 to sequentially establish the coordinates corresponding to the focal point O and the reference points R1, R2, ..., Rn in the brain image respectively. Positional relationship, in this way, the relative positional relationship between the sensing point P2 and the focus point O in the image can be established.

Afterwards, in step S606 , the image-to-space conversion correction procedure is performed. The navigation system starts to identify the spatial position of the sensing point P2 (at this time, P1 is a fixed coordinate and also appears on the screen). The relative spatial position between the reference point P1 and the sensing point P2 is used, and the spatial coordinate correction of the relative position of P2 is performed with reference to R1, R2, . . . , Rn. At this time, with the assistance of the calibration tracker 24 , a comparison is performed between the spatial position and the relative position of the image coordinates to determine whether the spatial position is consistent with the image coordinates. After the focused ultrasonic focus correction is completed, the T-shaped dummy 26 is removed. At this time, the surgical navigation system can identify the virtual focus position O of the focused ultrasound, and can determine the target point where the ultrasound is intended to be aimed at.

Afterwards, as shown in FIG. 5C to FIG. 5D , the present invention continues to tie the ultrasonic probe 106 to the water bag 50 and put it on the sliding track 302 . The focus position of the ultrasonic wave will be continuously tracked by the navigation system. Figure 4D is a schematic diagram of the focused ultrasonic treatment on the track of the ultrasonic probe frame after this calibration procedure. In this case, the actual position of the target point can be accurately known by P1 and P2 appearing on the screen at the same time. At this time, the focused ultrasonic wave can release the focused energy on the target point.

From the above, it is obvious that the device proposed by the present invention is a fast, efficient and accurate way to guide focused ultrasonic energy to aim at the target point. The reason is that the focal point of focused ultrasound is usually a few centimeters or even more than 10 centimeters away from the probe body, and the focal point is only about the size of a grain of rice. Take advantage of the technology's ability to precisely focus energy on specific target points. According to the embodiment of the present invention, combined with the surgical navigation system to guide the focused ultrasound, it is suitable for the parts that can be operated by the surgical navigation system. It can not only be applied to the brain to open the blood-brain barrier for brain drug release, but also can be applied to other parts of the body. Fixed-point heating and cauterization of deep tissues of the central system, local or deep cell stimulation and regulation, increase of local vascular permeability, local thrombolysis, and local drug release, etc.

Fig. 7 is a display diagram of the MRI experimental results of using the surgical navigation system to guide the focused ultrasonic energy to release energy to open the blood-brain barrier in the brain of the animal according to an embodiment of the present invention, which is to use the surgical navigation system to guide the focused ultrasonic energy to open the intracranial The blood-brain barrier increases its vascular permeability. In this animal (young pig) experiment, after the above-mentioned focus correction procedure, pulsed ultrasonic waves are used to perform ultrasonic stimulation on locally selected target points. During the process, microbubbles are also pushed into the animals to enhance their effects. Afterwards, the animals were placed back in the MRI room for scanning to verify the effect of focused ultrasound treatment guided by the surgical navigation system. The MRI contrast agent is pushed during the process, so if the local vascular permeability increases, the MRI contrast agent (Gd-DTPA) will leak into the brain tissue. During the process, the distance between the target point and the actual developer leakage is actually measured. Among them, 1 and 2 in the coordinate 1 in the first column of Fig. 7 are the target points, and 1 and 2 in the coordinate 2 in the fourth column are the positions where the effect actually occurs. The T1 scanned in columns 1 and 2 in the diagram is used to detect whether the animal to be tested is produced during the first radiography (contrast before focused ultrasound treatment) and the second radiography (contrast after focused ultrasound treatment) Displacement; Columns 2 to 4 clearly show the position of increased vascular permeability. The arrow points to the target point of the visible focus and the actual position where the effect is produced, and the distance is only 1.5 and 0.7mm (as shown in the enlarged diagram of areas 1 and 2 in the lower right corner of the diagram). The experimental results show that the target point can successfully guide the ultrasonic energy to the brain with the assistance of surgical navigation. During the guidance process, MRI is not used for full monitoring, and the distance error generated by it is the current surgical navigation applied to the actual human body. The generated errors are quite close, which proves that the technical features disclosed in the present invention are indeed usable and effective.

Next, FIG. 8A is an analysis diagram of R1 according to the point indicated by the arrow in FIG. 7 after ultrasonic focusing (ie focused ultrasonic treatment). FIG. 8B is an analysis diagram of brain regions obtained according to the same experimental parameters. As shown in Figure 8A to Figure 8B, it can be found that the blood-brain barrier (Blood Brain Barrier, BBB) can have a higher quantitative concentration (by measuring the R1 relaxation rate (relaxation rate) of MRI, about greater than 4/s) and a higher Gd - DTPA deposition rate (about 1.05mM). Moreover, at least 0.5mM Gd-DTPA can be effectively introduced into the brain tissue through ultrasonic focusing, effectively achieving the purpose of local drug release.

Next, FIG. 9A and FIG. 9B are data diagrams of experimental results of using a surgical navigation system to guide multi-point focused ultrasound (multi-point FUS) to release energy in the brain of an animal to open the blood-brain barrier according to an embodiment of the present invention, wherein each ultrasound focus The point is that the interval is 5mm, and 3×3=9 times are applied. It can be seen from the two figures that the effective opening diameter of the blood-brain barrier is 20mm, which is much larger than the single-point focusing of 4mm. It is obvious that the effect of opening the blood-brain barrier can be achieved by multi-point focused ultrasound.

Furthermore, Fig. 10 is a diagram showing the difference data between the target point focused by the present invention and the position where the effect is actually produced. It can be seen from Fig. 10 that the difference between the two is only 2.3±0.9mm, and the error produced by it is quite small , confirming that the technical features disclosed in the present invention are indeed available and effective.

Furthermore, since the focused ultrasonic energy is often not distributed in a point, it is closer to a three-dimensional distribution in a region. Therefore, if the guidance can identify an "energy zone" rather than an "energy point", it will make the guidance process more accurate. 11A to 11D are structural schematic diagrams of an aligner using multi-point focused ultrasonic waves according to another embodiment of the present invention, which mainly enables the aforementioned T-shaped dummy 26 to perform a three-dimensional area correction. 11C and 11D are respectively a top view and a side view of the ultrasonic probe 106 according to FIG. 11A . FIG. 11B is a partially enlarged view of the focal region 107 obtained according to FIG. 11A . It can be seen from the above diagrams that the multi-point focused ultrasonic alignment device is designed to allow the surgical navigation system to perform multiple calibration procedures in order to define and identify the distribution of focal areas in three-dimensional space, as shown in the diagram. As shown in points O1 to O6 (representing that the alignment device of the focused ultrasonic wave performs six point calibration procedures), but in this embodiment, the 50% sound pressure line is used as a definition to make it consistent with the single There is a difference in focus.

Fig. 12A to Fig. 12B are schematic diagrams of focusing areas using multi-point focused ultrasonic waves according to an embodiment of the present invention, which include the manual (manual) operation mode shown in Fig. 12A and the positioning mode using fixed rails shown in Fig. 12B , as shown in Figures 12C and 12D, can achieve the purpose of covering a large focus area in three-dimensional space. The released real-time control strategy, shown by the thicker line, is distributed through the 3D focus area defined in FIG. 11B .

It is worth noting that, according to the embodiment of the present invention, if the permeability of blood vessels in the brain increases, it may be accompanied by the generation of sub-harmonics or super-harmonics on the ultrasonic echo; otherwise, in the local brain through When the permeability has not been increased, sub-harmonic or super-harmonic will not be generated. Therefore, the present invention monitors the generation of sub-harmonic or super-harmonic in real time during the application of ultrasonic waves, so as to decide whether to stop the output of ultrasonic energy. Figures 13A and 13B are schematic diagrams of subharmonic (subharmonic; 0.5×fc, fc refers to the center frequency of focused ultrasonic waves), and Figures 13C and 13D show their superharmonic (ultraharmonic; 1.5×fc, fc refers to focused ultrasonic waves Schematic diagram of the center frequency). According to the detection of this characteristic echo, whether the permeability of local blood vessels has changed can be detected in real time.

FIG. 14 is a real-time control strategy for drug release in the brain using single or multiple focused ultrasound according to an embodiment of the present invention. The multi-point focusing control process is shown in FIG. 14, including steps S111 to S127.

As shown in steps S111-S119, after the system starts, it first acquires the previously captured brain images of the patient and performs registration and calibration, and then selects an area and begins to focus ultrasound. Then, in step S121 , it is detected whether the focused spectrum (spectrum) changes (whether a sub-harmonic or a super-harmonic is generated), and if so, the ultrasonic focusing is stopped (refer to step S123 ). Otherwise, return to step S119 to continue ultrasonic focusing.

Then, after step S123, the system will detect again whether all focus areas have been completely covered, if yes, execute step S127 to end the process, otherwise return to step S117 to resume focusing.

Among them, it is worth noting that the correction procedure performed in step S115 is to define the distribution of the 3D focal area and determine whether the vascular permeability is increased by using the spectrum change, so as to perform treatment on the next area until all areas are covered. , the calibration procedure is carried out in accordance with the calibration points O1 to O6 in Figure 11B.

To sum up, the present invention proposes a system and an operation method for using a surgical navigation system to guide focused ultrasonic energy to release energy. Guide to release energy to the part to be treated.

According to the technical features disclosed in the present invention, the system and its operation method implemented in the present invention can utilize the clinically used surgical navigation system to conduct focused ultrasonic energy guidance, therefore, there is no need to integrate the focused ultrasonic device and the MRI system , relatively reducing the cost of equipment, and increasing the flexibility of the operating system.

The above-described embodiments are only for illustrating the technical ideas and characteristics of the present invention, and its purpose is to enable those who are familiar with this art to understand the content of the present invention and implement it accordingly. When it is impossible to limit the patent scope of the present invention, That is, all equivalent changes or modifications made according to the spirit disclosed in the present invention should still be covered within the patent scope of the present invention.

Claims (18)

1. A system for guiding focused ultrasonic waves to release energy with a surgical navigation system, characterized in that it is used to guide a focused energy at a target point, the system comprising: a focused ultrasound device that generates a focal point, the focused ultrasound device releases the focused energy at the target point; A surgical navigation system, which is electrically connected to the focused ultrasonic device, the surgical navigation system includes a calibration unit, the calibration unit is to establish the positional relationship between the focal point and an image of a body to be treated, and execute a calibration coordinate calibration program, and make the surgical navigation system identify the focal point to determine the target point; wherein the calibration unit provides a first tracking point and a second tracking point, wherein the first tracking point provides a fixed reference coordinate, which is set at The second tracking point is set on an ultrasound probe of the focused ultrasound device at a place where there will be no relative position change with the part to be treated of the individual; and A fixing jig is used to fix the part to be treated of the individual. 2. The system for guiding focused ultrasonic waves to release energy with a surgical navigation system according to claim 1, wherein the focused ultrasonic device comprises: A signal generator, which outputs an ultrasonic signal; a signal amplifier, electrically connected to the signal generator, to amplify the ultrasonic signal into the focused energy; and The ultrasonic probe is electrically connected to the signal amplifier to release the focused energy at the target point, wherein the center frequency of the focused energy resonates with the ultrasonic probe. 3. The system according to claim 2, wherein the focused ultrasonic device is guided by a surgical navigation system to release energy, wherein the focused ultrasonic device further comprises: a power measuring device, the power measuring device is electrically connected to The ultrasonic probe is used to measure the energy magnitude of the focused energy. 4 . The system for guiding focused ultrasonic energy release by a surgical navigation system according to claim 2 , wherein the ultrasonic signal is a sinusoidal signal. 5. The system according to claim 1, wherein the surgical navigation system guides the focused ultrasonic energy release system, wherein the surgical navigation system comprises a computer unit, which records the image of the individual's part to be treated, so that the The computer unit completes the calibration procedure according to the image of the subject's part to be treated, the focal point of the focused ultrasonic device, and the first and second tracking points. 6. The system for guiding focused ultrasonic energy release by a surgical navigation system according to claim 1, further comprising a dummy and a correction tracker, wherein the dummy is used to assist the correction tracker Point out the position of the focal point of the focused ultrasonic device in space. 7 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 6 , wherein the dummy is set on an ultrasound probe of the focused ultrasound device. 7 . 8. The system for guiding focused ultrasonic waves to release energy with a surgical navigation system according to claim 1, wherein the fixing fixture includes a sliding track and a fixed track, and an ultrasonic probe of the focused ultrasonic device is set on the sliding track. 9. The system for guiding focused ultrasonic energy release by a surgical navigation system according to claim 8, wherein the fixing jig further comprises a fixing mechanism, and the fixing mechanism is used to enable the individual to pick up the to-be The part to be treated of the individual is worn and fixed when the image of the part is processed. 10 . The system for guiding focused ultrasonic waves to release energy by a surgical navigation system according to claim 9 , wherein the fixing mechanism is a thermoplastic mold. 11 . 11. The system for releasing focused ultrasonic energy guided by a surgical navigation system according to claim 1, wherein the focused energy is used for thermal ablation, local or deep stimulation of cells, local or deep regulation of cells, and increase of blood vessel Permeability, local thrombolysis or local drug release. 12 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 1 , wherein the focused energy is used to open the blood-brain barrier of the brain. 13 . 13 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 1 , wherein the focused ultrasound device is a multi-point focused ultrasound device. 14 . 14 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 1 , wherein the image of the part to be treated of the individual is an image of magnetic resonance imaging or computer tomography. 15 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 1 , wherein the target point is located at a place where the surgical navigation system can operate and guide. 15 . 16. The system for guiding focused ultrasonic energy release by a surgical navigation system according to claim 15, wherein the target point is located in the tissue of the central nervous system. 17 . The system for guiding focused ultrasound to release energy by a surgical navigation system according to claim 16 , wherein the target point is located in tissue covered by hard tissue. 18 . 18. The system for guiding focused ultrasonic energy release by a surgical navigation system according to claim 17, wherein the target point is located in the brain or spinal cord.